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Failings in National Health Service (NHS) care for patients with mental health problems is a worryingly persistent story in the English media. Many reports show harrowing and dramatic failings in NHS care provision for the mentally ill some of which result in avoidable deaths.The Health Service Ombudsman (HSO) represents the final stage in the NHS complaints procedure and is an independent office reporting directly to Parliament.The HSO carry’s out investigations into complaints and makes the final decisions on those that have not been resolved by the NHS in England.In a recently published report the HSO reveals reveals unjust, shocking and tragic failings in NHS care provision for patients with mental health problems.Some mental health care complaints figures are given in the report.In 2016-2017 there were 14,106 complaints made to NHS mental health trusts (hospitals) with ,65% being upheld or partly upheld by the local organisation.Case work data between 2014-15 and 2017-18 was analysed and five key themes showing persistent failings that the HSO see in complaints being made emerged from this exercise:

Diagnosis and failure to treat.

Risk assessment and safety

Dignity and human rights.

Communication.

Inappropriate discharge and provision of aftercare.

The HSO also points out in the report that the other common factor in the cases examined is too frequent substandard complaint handling by the NHS organisation. This adds insult to injury, compounding the impact of failings. Continue reading →

Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.

Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.

Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”

By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]

Imagine a clinical research protocol to test the efficacy of a nutritional regime on the aging trajectory of the participants. Such a study would need to be highly powered and include thousands of people in order to observe a credible effect size. Participants would remain enrolled in the study for many years, maybe decades. Endpoints would include novel measures of healthy aging such as functioning (the capacity to perform certain activities) and the quality of social life. Participants would thus be asked to provide enormous amounts of personal data covering at the same time their health state, their habits and their social activities – most likely with the help of smart appliances, sensor-equipped wearables, mobile phones and electronic records.

In a different scenario a research team aims to develop clinical protocols for cancer treatment according to the unique genomic signature of their tumor. They will need patients, willing to undergo whole genome germline and tumor sequencing right at the moment of diagnosis and be included in a basket trial. Therapy would then be targeted to the specific genetic alterations of each individual in the hope that a combination of targeted drugs would generate better medical outcomes than the current standard of care.

These two scenarios correspond to the prototypical form of, respectively, precision medicine and precision oncology studies. The first is likely to require large (very large) longitudinal cohorts of extensively characterized individuals – like the All of Us Research Program. The second will require sustained sharing of genomic data, information on patients’ clinical history and response to treatment, and possibly a unique repository in which such information would flow to – something akin the NCI’s Genomic Data Common.

This kind of data-intense research, in particular, introduces game changing features: increased uncertainty about foreseeable data uses, expanded temporal span of research activities due to virtually unlimited data lifecycles, and finally, the relational nature of data. This last feature refers both to the fact that, for instance, zip codes contain other types of sensitive information like information about ethnic background (redundant encoding); and to the fact that data about one person contain information about others– as is the case, for instance, with genetic data among family members. Continue reading →

Join the Center for Health Law and Policy Innovation for a panel discusison with leading health care journalists about the rapidly shifting health policy landscape in Washington DC. The panel will discuss the high drama of a tumultuous year in health policy that has seen repeated congressional attempts to repeal the Affordable Care Act, the resignation of a cabinet secretary amidst scandal, and a steady effort to undermine Obama-era priorities. Further, the panel will explore the role of journalism in modern policy-making, and how social media impacts the dialogue.

Join the Center for Health Law and Policy Innovation for a panel discusison with leading health care journalists about the rapidly shifting health policy landscape in Washington DC. The panel will discuss the high drama of a tumultuous year in health policy that has seen repeated congressional attempts to repeal the Affordable Care Act, the resignation of a cabinet secretary amidst scandal, and a steady effort to undermine Obama-era priorities. Further, the panel will explore the role of journalism in modern policy-making, and how social media impacts the dialogue.

Patients shouldn’t be penalized by their biology if they need a drug that isn’t on formulary. Patients shouldn’t face exorbitant out of pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries, or is used to buy down the premium costs for everyone else. After all, what’s the point of a big co-pay on a costly cancer drug? Is a patient really in a position to make an economically-based decision? Is the co-pay going to discourage overutilization? Is someone in this situation voluntary seeking chemo? Of course not. Yet the big co-pay or rebate on the costly drug can help offset insurers’ payments to the pharmacy, and reduce average insurance premiums. But sick people aren’t supposed to be subsidizing the healthy.

Wow. This may seem like common sense to some readers, but it is revolutionary to hear from a senior American government official, and indeed a Republican one no less.

In a new paper, Victor Laurion and I have chronicled the ways in which American politicians at the highest levels have blindly embraced the opposite point of view for half-a-century. This sort of ideological adherence to simplistic economic reasoning (which James Kwak calls ‘economism‘) is why U.S. health insurance exposes patients to all sorts of deductibles, copays, and coinsurance. As a result, even insured Americans find themselves “underinsured” — denied access to care or falling into bankruptcy if they stretch to pay nonetheless. Continue reading →

A common theme found in patient safety reports in England going back as far as the year 2000 is that the NHS (National Health Service) is poor at learning lessons from previous adverse health incident reports and of changing practice. The seminal report on patient safety in England, Organisation with a memory in 2000 stated:

“There is no single focal point for NHS information on adverse events, and at present it is spread across nearly 1,000 different organisations. The NHS record in implementing the recommendations that emerge from these various systems is patchy. Too often lessons are identiﬁed but true ‘active’ learning does not take place because the necessary changes are not properly embedded in practice.” (x-xi).

In late 2003 our NRLS (National Reporting and Learning System) was established.This is our central database of patient safety incident reporting. Can we say today that the NHS is actively learning from the adverse patient safety incidents of the past and changing practice? That the NRLS has been a great success? Or is the jury still out on these questions? Unfortunately the jury is still out. Sadly, there is no shortage of contemporary reports saying that the NHS still needs to improve its lesson learning capacity from adverse events.

This week features a first time visit from Carl Ameringer, professor of health policy and politics at Virginia Commonwealth University in Richmond, Virginia. A lawyer with a PhD in political science, he is an expert on issues surrounding our national debate on health care reform. We discuss his latest book “US Health Policy and Health Care Delivery: Doctors, Reformers, and Entrepreneurs,” published by Cambridge University Press. Our conversation connects the past and future of American health care, from 19th century development to the ACOs of the ACA. We close with some reflections on path-dependence: is American exceptionalism a permanent impediment to health sector rationalization, or does it provide some models for improvement? Muddling through history, policy, and law has rarely been more edifying, and we hope you enjoy the conversation as much as we did.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher RadioTunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

UK national and social media have been buzzing all last week about a letter sent on Monday 29th January 2018 by the NHS Confederation to the Justice Secretary and copying in the Secretary of State for Health.BBC news set the scene under the banner headline, ‘Curb rising NHS negligence pay-outs, health leaders urge’.

The NHS Confederation is a charity and membership body that brings together and speaks on behalf of all organisations that plan, commission and provide NHS services. Members are drawn from every part of the health and care system. The letter coordinated by them had several co-signatories in the medical establishment including the Chief Executives of the doctor’s defence organisations, the British Medical Association (BMA), The Academy of Medical Royal Colleges. The letter said that the current level of NHS compensation pay-outs is unsustainable and is diverting significant amounts of funding away from front line care services. Last year the NHS spent £1.7 billion on clinical negligence claims, representing 1.5 % of front line health services spending. This annual cost has almost doubled since 2010/11 with an average 11.5 % increase every year:

Arguably the most popular provision of the Affordable Care Act (ACA), section 2714 (42 U.S.C. § 300gg-14) provides that individuals may stay on their parent’s insurance plan until they are twenty-six years of age. A 2013 Commonwealth Fund survey found 7.8 young adults gained new or better insurance through this ACA provision, and a repeat survey in 2016 found the uninsured rate for young adults, ages 19-34, dropped from 28% to 18%. On its face, it is difficult to find any harm caused by this provision. Healthy young people have insurance, despite continuing education or lack of gainful employment, and are presumably lowering costs by being in the risk pool. However, this provision can lead to unforeseen pitfalls, including medical debt, because of the way it interacts with the growing trend of increased cost sharing and narrow networks. These trends acutely impact students in higher education, because students who study even a modest distance from their parents’ home are unlikely to have access to nearby “in-network” providers, and because students’ medical needs more often tend to come in the form of unexpected emergencies. In this post, I will highlight my personal experience with Section 2714, as a graduate student, and explore policy and possibilities for reform.

An Emergency and a Choice: Applying Section 2714

Like many young adults, I remained on my parents’ insurance when I went to college. Specifically, I remained on my mom’s insurance because I was in law school and continue to be an advocate for the ACA program. But when my mom began a new job at a different hospital her insurance changed and so did the medical network. The only “in network” coverage was through the hospital that employed her, and that was hour and forty-five minutes away. I didn’t view this as an issue until the unexpected happened. Continue reading →

It’s a stormy healthcare landscape out there, so this show is all lightning round. We cover several areas:

Litigation: Nic provides the Ariadne’s thread through a labyrinthine pharma-tort judgment out of California. The metal on metal hip litigation has resulted in a big judgment, but medical device regulation is still fundamentally broken. Disgruntled Centene enrollees are suing the ACA insurer of last resort for ultra-narrow networks (and Washington state is not happy, either). Washington may lead the way for future narrow network regulation or consent decrees. We followed up on the duodenoscope superbug litigation saga, focusing on duties to translate foreign language emails in discovery.

Like many other areas of law, protections against sex discrimination experienced dramatic fluctuation in 2017. Safeguards and norms thought to be firmly planted by the Obama administration were reversed. And because the field of anti-discrimination law tends toward cross-disciplinary borrowing of standards and interpretations, the effect of a single change—in employment or education, for example—is amplified in others, like health care. The year in sex discrimination proved to be a paradigmatic example of progressive advocates wanting badly for things to be one way, but it’s the other way (See Note 1).

In 2017, the apple of discord here involved interpretation of Title IX’s prohibition of discrimination “on the basis of sex.” Progressive advocates understand that phrase expansively, to encompass at least discrimination that occurs because of sex, gender identity, sexual stereotyping, and sexual orientation. Conservatives, unsurprisingly, interpret the language as narrowly delimited to distinctions made only on the basis of biological sex assigned at birth. We all bore witness to a severe swing of this pendulum in 2017. […]

Non-citizen immigrants are the canaries in the health care coal mine. Disproportionately poor, non-white, and non-English speaking, and without access to the franchise, they are among the most vulnerable groups in the United States. Consequently, they are often the first to experience the gaps, inefficiencies, and conflicts in our health care system. Meanwhile, anti-immigrant sentiment often spills into health policy debates, as was evident in 2009 when opponents of the bill that became the Affordable Care Act (ACA) focused their opposition on the erroneous claim that it would cover undocumented immigrants. It is therefore not surprising that the first year of the Trump administration, which has focused its domestic agenda on restricting immigration and repealing the ACA, has proven especially perilous for immigrants who need health care.

As a group, immigrants tend to be healthier than the native-born population. They are also far less likely to have insurance. In 2015, for example, 18 percent of lawfully present nonelderly adult immigrants, and 42 percent of undocumented immigrants were uninsured, compared to only 11 percent of United States citizens. Immigrants’ low insurance rate is partly due to the fact that they disproportionately work in sectors of the economy in which employer-sponsored insurance is uncommon. But the law also plays a significant role. Even before the Trump administration took office, immigrants faced an array of legal barriers to obtaining health insurance. Most importantly, the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PROWRA) prohibited undocumented immigrants from accessing most federally-funded insurance programs (including Medicaid, Medicare and Children’s Health Insurance Program (CHIP)). PRWORA also barred most authorized immigrants (except refugees) from benefiting from federally-funded programs for five years after obtaining legal status. And although the ACA made it easier for many documented immigrants to gain coverage, it left PROWRA in place. The ACA also limited participation in the exchanges to immigrants who are “lawfully present,” a category that the Obama administration decided did not include the approximately 800,000 young adults who participated in the Deferred Action for Childhood Arrivals (DACA) program. […]

For more than 50 years, Medicaid has been our nation’s health care safety net. Medicaid allows our lowest-income, sickest, and often most vulnerable populations to get care and treatment, and supports the health of more than 68 million Americans today. As an entitlement program, Medicaid grows to meet demand: There is no such thing as a waiting list. This vital health program found itself under fire in 2017, and while there were no major reductions in funding or enrollment, it is far from safe in 2018. Whether by new legislation or actions the Trump administration may take, the threats to Medicaid are not going away anytime soon.

Congressional Threats To Medicaid’s Expansion, Structure, And Funding

Throughout 2017, Republicans tried unsuccessfully to roll back the Affordable Care Act (ACA), including the law’s expansion of Medicaid. Underpinning each effort was the oft-stated belief, held by Republican leadership, that the expansion was a disastrous move that extended coverage to more than 12 million able-bodied people who should not be getting health insurance from the government. While these unsuccessful efforts were commonly referred to as attempts to “repeal and replace the ACA,” every bill that gained any traction in 2017 went far beyond repealing only the ACA’s Medicaid expansion. The proposals also included plans to fundamentally alter the way in which the traditional Medicaid program is structured and paid for. […]

In tort law we have a very well-known Latin phrase, ‘Res Ipsa Loquitur’ (the thing speaks for itself). An inference of negligence can be raised by the events that occurred. In the National Health Service (NHS) in England there is a similar concept,‘the Never Event’. The Never Event concept is a USA import into the NHS and was introduced from April 2009. The list of what is to be regarded as a Never Event has been revised over the years in the NHS and is currently set out by NHS Improvement.

Never events include, wrong site surgery, wrong implant/prosthesis, retained foreign object post procedure, mis-selection of a strong potassium solution, administration of medication by the wrong route and so on. Never Events are defined in NHS policy documentation as:

“…patient safety incidents that are wholly preventable where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and have been implemented by healthcare providers. Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event.” (p.6)Continue reading →

Efforts to repeal and replace the coverage expansions in the Affordable Care Act (ACA) as well as the tax increases that financed them were persistent throughout 2017. Even after the congressional Republicans’ highly visible failures earlier this year, they kept coming back—finally succeeding in zeroing out the penalties in the ACA’s individual mandate as part of federal tax cut legislation signed into law in late December.

Of keen interest and importance now is the question: What’s next for the ACA?

Originally, many ACA supporters assumed during the years of the Obama administration that once the law’s major coverage provisions took effect in January 2014, the reality on the ground of a successful coverage expansion and broader insurance benefits would transform the ACA into a popular program—growing in acceptance and inevitability as Social Security, Medicare, and Medicaid all did before it. […]

The effective repeal of the federal individual mandate represents one of the most significant changes to the Affordable Care Act (ACA) since its implementation. Especially on the heels of the federal government’s sudden withdrawal of cost-sharing reduction payments this past October, the instability that the federal mandate repeal could introduce to health insurance markets is material. However, states can craft reaction strategies to protect against such effects.

In Massachusetts, where I manage policy and strategy for the state-run insurance exchange, we’ve now spent a decade administering our own state-based individual mandate. And, while our state is unique in many ways—our experience may prove useful to policy makers in other states considering locally tailored pathways to maintaining coverage gains. State-administered mandates or alternative policies to encourage broad coverage across a state’s population can be a tool to foster premium stability and healthy issuer participation, but we have found that mandates can also introduce extra advantages such as the promotion of consistent benefit floors and enabling effective outreach to the uninsured. […]

Over the past few years, more and more global health luminaries and leading NGOs have called for a Framework Convention on Global Health (FCGH), for using the strongest instrument of international law to advance the quest for health equity.

In the globalization era, the highest attainable level of health cannot be achieved by States acting on their own. A FCGH treaty would facilitate the coordinated global effort needed to achieve the highest attainable level of health everywhere. It would reform global governance for health to enhance accountability, transparency, and civil society participation and protect the right to health in trade, investment, climate change, and other international regimes, while catalyzing governments to institutionalize the right to health at community through to national levels.

The FCGH Alliance membership includes more than 30 organizations and individuals from Africa, Asia, Latin America, North America, and Europe that believe that unconscionable global and local health inequities are fundamentally unjust.

We know this is an ambitious undertaking, but we are convinced that a FCGH would be a historical shift in global health.

Congress has been busy enacting and proposing changes to the Affordable Care Act (ACA)’s regulation of private health insurance, from repealing the tax on individuals without minimum essential coverage to the Alexander-Murray bill intended to shore up the private market. These changes do not play well together. Three reasons are explored here: the great wall, which divides advocates with different goals; whipsawed insurance markets, in which insurers are simultaneously pulled in different directions; and, of course, the cost of care, which each reform shifts onto different entities.

The Great Wall

A great ideological wall makes it almost impossible to reach national consensus on whether or how to regulate private insurance markets. The wall divides people—especially in Congress—who believe in personal responsibility for one’s health care costs from those who believe in social responsibility for many such costs or social solidarity. The former believe that you are responsible for your own health and you should be free to buy (or not buy) health care and health insurance as you choose. In this view, health insurance is a commercial product that is properly priced according to actuarial risk. Ideally, competition among insurers can produce affordable products of reasonable quality.

Those who favor in social responsibility for health care believe that health depends on more than personal behavior; it depends on the social determinants of health, including education, income, occupation, housing, and environmental factors. This view recognizes that illness is not always predictable and millions of people cannot afford needed health care. (Many also believe that access to health care is a human right as set forth in the Universal Declaration of Human Rights.) In this view, insurance is not a commodity, but a method of financing health care that should be available to all in need, and therefore a social responsibility. To enable everyone to have access to affordable care within a private market, government must regulate private insurers (and providers) more extensively than would be necessary in a public insurance system. […]

Congress has enacted a tax bill that repeals the Affordable Care Act (ACA) penalties for individuals who fail to enroll in health insurance. Open enrollment for the 2018 plan year may stay roughly even with 2017 exchange enrollment—lackluster performance that some blame on what they call “Trump sabotage”. Some Republicans are urging Congress to appropriate funds for cost sharing reduction (CSR) payments and a national reinsurance pool, presumably to promote enrollment and moderate premium increases. Will Democrats vote to resolve the CSR problem and reinstitute reinsurance—policies many say they support? Or will it be business as usual on Capitol Hill with strict party-line votes (and the inevitable failure of ACA fixes)? Would that change anything about the way the nongroup insurance market operates next year?

The short answers are no, yes, and no. Here are some thoughts about why the status quo is likely to remain largely undisturbed by political speech-making and over-reaction from the editorial pages. My comments are based loosely on my presentation at the Petrie-Flom Health Law Year in P/Review conference held at Harvard University on December 12, 2017.

Exchange Enrollment For 2018

Early reports showed a more rapid pace of exchange enrollment this year than last. As of December 15, 2017, 8.8 million people in the 39 states using the federal exchange had selected plans. That is less than last year’s total of 9.2 million enrollments through Healthcare.gov, but not the dramatic reduction that advocates may have expected. […]